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GAO Sustains For Failure To Set Aside For Small Business

Client Alert | less than 1 min read | 10.20.04

In Information Ventures, Inc. (Oct. 8, 2004), GAO sustained a pre-award protest of an unrestricted procurement because the agency failed to take reasonable efforts to ascertain whether at least two small businesses were capable of performing the work, and, in fact, that the agency ignored known information that there were at least two small businesses that could have done so. Lesson learned from this case is that small businesses should carefully monitor the issuance of unrestricted procurements and object prior to the submission of proposals (due to strict GAO timeliness rules) if they believe that multiple small business are capable of performing the work.

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Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....